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Omron HEM-7250-IT

Omron HEM-7250-IT
Device Model:HEM-7250-IT
Manufacturer:Sole: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Omron HEM-7250-IT is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for self-measurement and home use.
Assessment:

The technology used in the Omron HEM-7250-IT, to measure blood pressure, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
ESH (Europe)Self-measurementPublished evidence

Device Family:Omron HEM-7250-ITD, Omron HEM-7251GD (D DET Equivalence)
Validation Publications for Equivalent Devices

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Omron HEM-7251G

Takahashi H, Yoshika M, Yokoi T. Validation of two automatic devices: Omron HEM-7252G-HP and Omron HEM-7251G for self-measurement of blood pressure according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2015 Oct;20(5):286-90. Epub: 2015 Apr 29. doi: 0.1097/MBP.0000000000000127. PMID: 25932887.

ESH-IP:2010 - Pass General population